2024-510816-55-00招募中2 期
Safety and Efficacy of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Candidemia
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 18
- 主要终点
- Time to first negative blood culture.
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy and safety of rIFN-γ as adjunctive treatment in combination with standard therapy for the treatment of patients with candidemia. Efficacy is defined as clearance of candidemia within the first 7 days of treatment, taking into account mortality.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Males or non-pregnant females (who must agree to use barrier methods of contraception during the study therapy period, women of childbearing age must have a negative urine pregnancy or serum test at baseline).
- •Subjects who are 18 years of age or older.
- •Subjects with at least one positive blood culture isolation of Candida species from a specimen drawn within 120 hours prior to study entry.
- •Subjects who have clinical evidence of infection sometime within 120 hours prior to enrolment, including at least one of the following: - Temperature >37.8 ˚C on two occasions at least four hours apart or one measurement > 38.2 ˚C - Systolic blood pressure <90 or a >30 mmHg decrease in systolic blood pressure from the subject's normal baseline or the need for vassopressive therapy. - Signs of inflammation (swelling, heat, erythema, purulent drainage) from a site infected with Candida (e.g. joint, skin, eye, bone, oesophagus). - Radiologic findings of invasive candidiasis.
- •Subject or their legal representative must sign a written informed consent form
排除标准
- •Subjects with a history of allergy or intolerance to rIFN-γ,or any other IMP ingredient or with a history of immediate type hypersensitivity to latex/rubber.
- •Patients with renal failure or dialysis do not have a contraindication for treatment with rIFNy and can be included in this study.
- •Subjects with a history of documented epileptic seizures.
- •Subjects with severe liver failure ((>5x upper limit AST or ALT or impaired synthesis of proteins such as coagulation factors manifested by increased prothrombin time)
- •Treatment with heterologous serum proteins, or immunological preparations such as vaccines, toxins, serums and allergens within three days before trial enrolment.
- •Women who are pregnant or lactating.
- •Subjects who are unlikely to survive more than 24 hours.
- •Subjects who have failed previous systemic antifungal therapy for the Candida spp. infection which is being studied.
- •Subjects who have received more than 120 hours of systemic antifungal therapy for the current episode, within 120 hours prior to study entry.
- •With respect to incapacitated subjects: • Any patient that is deemed incapable of personally providing informed consent due to a neurodegenerative disease, genetic syndrome, and/or perinatal asphyxia, will not be eligible for inclusion in this trial. • Any incapacitated subject that is not expected to recover to a point where they will personally be able to provide informed consent will not be eligible for inclusion in this trial.
结局指标
主要结局
Time to first negative blood culture.
Time to first negative blood culture.
次要结局
- Time of resolution to infection (composite endpoint).
- Percentage of patients with mycological outcomes at EOST, EOT, and day 14 and day 28 after EOT.
- Percentage of patients with treatment success at EOST, EOT, and day 14 and day 28 after EOT.
- Overall survival at Study Day 28.
- Number of patients with Treatment Emergent Adverse Events (TEAEs).
- Evaluation of patient status at end of rIFN-γ treatment including organ (dys)function (Sequential Organ Failure Assessment [SOFA] score), and adverse events
- Nutritional status (body weight, BMI), nutritional blood parameters (prealbumin, total lymphocytes, cholesterol).
- Genetics and transcriptomics.
- Gut microbiota composition and Candida genomics and metabolomics
- Changes in circulating cytokines, biomarkers, LAP activation, inflammasome, and immunoprofiling.
研究者
Frank van de Veerdonk
Scientific
Stichting Radboud University Medical Center
研究点 (18)
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